Lead Clinical Research Specialist

2 weeks ago

Seattle, Washington, United States Aequor Inc Full time

Job Title: Lead Clinical Research Specialist

Location: Seattle-Dexter, WA * Hybrid - The GDEPD department maintains an 80% onsite requirement for all laboratory-based personnel, allowing for one day of remote work each week.

*Key Competencies:


• Required experience in Process Development


• Proven background in the creation of viral vectors (e.g., adeno-, retro-, lenti-), including successful transfer for GMP production


• Familiarity with upstream process intensification techniques such as fed-batch and perfusion development, as well as process-analytical technology (PAT)


• Proficient in suspension culture of mammalian cells using shake flasks and small stirred tank bioreactors


• Experience with transfection-based methodologies


• This role is highly technical and lab-focused. The ideal candidate will possess recent experience in a comparable position (not in manufacturing or team leadership).

The specialist will become a member of the LVV Platform Development team, engaging in vector biology and molecular optimization projects aimed at advancing next-generation viral vector platform development. The role involves comprehensive evaluation of innovative technologies and methodologies, with a focus on mastering upstream production and downstream purification of lentiviral vectors, while also gaining insights into LVV analytical techniques and their relevance to LVV characteristics and biology. The specialist will have the exceptional opportunity to explore a variety of cutting-edge molecular designs and collaborate with diverse teams involved in various aspects of LVV development.

Key Responsibilities:


• Generate materials for LVV to facilitate downstream processing


• Conduct and troubleshoot upstream and downstream process development experiments that support next-generation LVV production


• Oversee the management of sample and data flow, performing necessary analyses


• Assist in experimental design and data interpretation


• Provide experimental design and execution support to colleagues in related functions (e.g., clinical development programs, high-throughput process development, etc.)


• Support the transition from research to development, including early-stage molecular assessment activities


• Actively engage in lab maintenance and continuous improvement initiatives


• Maintain a precise and comprehensive laboratory notebook and documentation


• Summarize and present findings in team meetings, contributing to group discussions and strategic planning


• Author technical reports and study summaries

Basic Qualifications:


• STEM degree with a minimum of 2 years of relevant industry experience; title and compensation will be aligned with education, experience, and skill set


• Experience in suspension culture of mammalian cells using shake flasks and small stirred tank bioreactors


• Practical experience in process development


• Self-motivated with the ability to collaborate effectively in teams


• Strong communication skills, both verbal and written


• Ability to utilize literature and both internal and external resources to address challenges

Preferred Qualifications:


• Degree in biological or chemical engineering, biochemistry, or a related field


• Experience with JMP for Design of Experiments (DoE) design and analysis


• Background in the development of viral vectors (e.g., adeno-, retro-, lenti-), including successful transfer for GMP production


• Experience with downstream processing operations


• Knowledge of upstream LVV optimization


• Familiarity with transfection-based processes


• Experience with upstream process intensification techniques such as fed-batch and perfusion development, as well as process-analytical technology (PAT)


• Experience with single-use technologies

Additional Job Requirements:

This position involves handling hazardous materials.

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